To determine if the Shingrix vaccine is immunogenic for people living with HIV who are aged 50 and over or have perinatally acquired HIV infection and are aged 18 or over
- Conditions
- Herpes zoster (shingles) in people living with HIVInfections and Infestations
- Registration Number
- ISRCTN34192276
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 70
1. Able and willing to comply with the requirements of the protocol
2. Able and willing to provide fully informed consent
3. Male or non-pregnant, non-lactating females
4. People living with HIV >50 years and over OR have perinatally acquired HIV (any CD4) and are aged 18 years and over
5. If female, of child-bearing age, not sterilised and participating in sexual intercourse that could result in pregnancy, using at least one acceptable method of contraception when engaging in sexual activities that can result in pregnancy, beginning at screening through month 4. Acceptable methods of contraception include the following:
5.1. Hormonal contraception
5.2. Male or female condom
5.3. Diaphragm or cervical cap with a spermicide
5.4. Intrauterine device
1. Active herpes zoster disease in past 6 months preceding the first dose of study vaccine
2. If female, planning to get pregnant, currently pregnant (evidence from positive serum or urine pregnancy test), or breastfeeding
3. Used any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period
4. Vaccinated within the 12 months preceding the first dose of study vaccine or planned to be vaccinated during the study with a (non-study) vaccine against herpes zoster or varicella zoster virus
5. History of any reaction or hypersensitivity likely to be exacerbated by any vaccine component
6. Received or planned to receive a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine or had received or planned to receive a non-replicating vaccine within 8 days before or within 14 days after either dose of study vaccine
7. Acute disease and/or fever at the time of enrolment. Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting. The preferred route for recording temperature in this study will be oral. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
8. Chronic administration (defined as more than 15 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone < 20 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed. Drugs include: chemotherapeutic drugs, immunomodulators and systemic immunosuppressive treatments, oral glucocorticoids >20 mg/day, cyclosporine, methotrexate, interleukins and/or cytokines, immunotherapies (including TNF blockers).
9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
10. History of potential immune-mediated disease (pIMD). Note: If the subject has any condition on the list of pIMDs specified in the protocol, they must be excluded unless the aetiology is clearly documented to be non-immune mediated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Total VZV-specific cell-mediated response measured using ELISPOT in peripheral blood mononuclear cells (PBMCs) from baseline to week 12 (4 weeks after the second vaccine dose)<br>2. Total VZV-specific antibody measured using ELISA in plasma from baseline to week 12 (4 weeks after the second vaccine dose)
- Secondary Outcome Measures
Name Time Method 1. Evolution of VZV-specific cell-mediated response over the study period, measured at baseline (first vaccine dose), week 4, week 8, week 12, week 24 and week 48 (PBMCs)<br>2. Evolution of VZV-specific antibody over the study period, measured at baseline (first vaccine dose), week 4, week 8, week 12, week 24 and week 48 (plasma)<br>3. Occurrence of adverse events of Grade 2 or higher severity (from Electronic Data Capture [EDC]) between screening and week 48<br>4. Viral sequence of shingles infections (in swabs) measured using nucleic acid magnetic bead extraction and real-time RT-PCR (reverse transcription and polymerase chain reaction) to determine the presence of viral genes, viral titres and viral sequence at week 48